Implications of Self-weighing During Weight Loss Treatment

Overweight and Obesity Clinical Trial

Official title:

Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04032249
• Other study ID #: P5_A284R4156
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2019
• Source: Universidad de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to analyze the effectiveness of introducing behavioral elements in a weight loss program, in this case, comparing the difference between self-weighing versus not doing so.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 1, 2020
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having a IMC >25,

• Being sedentary and

• Have not been submitted to a restrictive diet in the 6 months preceding this study

Exclusion Criteria:

• Suffered from type 2 diabetes or renal conditions

• Being pregnancy or attempt at pregnancy,

• Undergoing antidepressant pharmacological treatment

Related Conditions & MeSH terms

• Behavior, Eating
• Body Weight
• Overweight
• Overweight and Obesity
• Signs and Symptoms
• Weight Loss

Intervention

Behavioral:
• Control Group (CG)
The control group is subjected to follow a hypocaloric diet and receives information about the benefits of having healthy habits in relation to decision making and food
• Intervention Group (IG)
The control group is subjected to follow a hypocaloric diet and receives information about the benefits of having healthy habits in relation to decision making and food, but also, they will have monitored the self-control of the weight in order to compare the impact of self-weighing versus not doing it

Locations

Country	Name	City	State
Spain	Universidad de Córdoba	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline BMI	Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale	At baseline (0 years) and followed for 2 years
Primary	Changes from baseline Fatty mass	Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.	At baseline (0 years) and followed for 2 years
Primary	Changes from baseline Free-fatty mass	Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.	At baseline (0 years) and followed for 2 years
Primary	Changes from baseline Muscular Mass	Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.	At baseline (0 years) and followed for 2 years
Primary	Changes from baseline Corporal Water	Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.	At baseline (0 years) and followed for 2 years
Primary	Adherence to dietary pattern will be also measured through personal interview	Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.	At baseline (0 years) and followed for 2 years